A Study to Evaluate the Safety and Efficacy of a Novel Contact Lens for Daily Disposable Use

Bausch & Lomb Incorporated1 site in 1 country173 target enrollmentJune 2011

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Bausch & Lomb Incorporated
Enrollment: 173
Locations: 1
Primary Endpoint: Slit Lamp Findings > Grade 2
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

October 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bausch & Lomb Incorporated

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must be myopic and require lens correction from -0.50 D to -6.00 D in each eye.
•Subjects must be correctable through spherocylindrical refraction to 40 logMAR letters or better (distance, high contrast) in each eye.
•Subjects must be free of any anterior segment disorders.
•Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months.

Exclusion Criteria

•Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
•Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
•Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
•Subjects who have had any corneal surgery (eg, refractive surgery).
•Subjects who are allergic to any component in the study care products.

Outcomes

Primary Outcomes

Slit Lamp Findings > Grade 2

Time Frame: 4 visits over 3 months

Statistical non-inferiority of Slit Lamp Findings \> Grade 2 at any visit between the Test and Control lenses

High Contrast, Distance logMAR Visual Acuity (VA)

Time Frame: 4 visits over 3 months

Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint